Tracheal intubation system including a laryngoscope

ABSTRACT

A tracheal intubation system including a laryngoscope is disclosed. An endotracheal tube exchange system is also disclosed. In some examples, the system includes a laryngoscope, a stylet, and an endotracheal tube. In some examples the stylet is an articulating stylet. An endotracheal tube with one or more depth-assessment bands is also disclosed. An articulating stylet with one or more depth-assessment bands and an orientation mark is also disclosed. A method of positioning an endotracheal tube in a patient is also disclosed. A method of positioning a stylet for placement of an endotracheal tube is also disclosed. A method of performing an endotracheal tube exchange procedure is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Application No. 61/886,315,filed on Oct. 3, 2013, and titled TRACHEAL INTUBATION SYSTEM INCLUDING ALARYNGOSCOPE, and to U.S. Application No. 61/929,785, filed on Jan. 21,2014, and titled TRACHEAL INTUBATION SYSTEM INCLUDING A LARYNGOSCOPE,the disclosures of which are hereby incorporated by reference in theirentireties.

BACKGROUND

Many surgical procedures are typically performed while the patient isunder general anesthesia. During these procedures, the patient is givena combination of medications to cause a loss of consciousness and muscleparalysis. The medications that cause loss of consciousness and muscleparalysis also interfere with the patient's ability to breath.Accordingly, patients often undergo tracheal intubation during theseprocedures so that the patient may be connected to an externalventilator or breathing circuit. Patients may also be intubated fornonsurgical conditions in which enhanced oxygen delivery is required.Tracheal intubation may also be used in other circumstances.

During tracheal intubation, an endotracheal tube is placed in thepatient's airway. Generally, the endotracheal tube is advanced throughthe patient's nose or mouth into the patient's trachea. The endotrachealtube is then connected to an external ventilator or breathing circuit.The ventilator is then able to breath for the patient, delivering oxygeninto the patient's lungs.

The patient's vocal cords and the space between them form the entranceto the trachea, these structures are also known as the glottis. Theglottis is visible from and may be accessed through the pharynx. Thepharynx is the portion of the upper airway that is located behind thepatient's mouth and below the patient's nasal cavity. The mouth and thenasal cavity meet in the pharynx. Additionally, the esophagus and theglottis may be accessed through the pharynx. During the intubationprocess, the endotracheal tube must be carefully advanced through thepatient's pharynx and placed through the vocal cords into the trachea.

The intubation process interferes with the patient's ability to breatheand thus deliver oxygen to the body independently. If the patient iswithout oxygen for more than two or three minutes, tissue injury mayoccur, which can lead to death or permanent brain damage. Accordingly,the intubation process must be performed quickly and accurately.

SUMMARY

In general terms, this disclosure is directed to a tracheal intubationsystem including a laryngoscope. The equipment and methods in thisdisclosure may also be used in endotracheal tube exchange procedures. Inone possible configuration and by non-limiting example, the trachealintubation system allows a caregiver to properly position anendotracheal tube in a normal or difficult airway quickly, accurately,and safely. In another configuration and by non-limiting example, thetracheal intubation system allows a caregiver to properly perform anendotracheal tube exchange procedure quickly, accurately, and safely.

One aspect is a tracheal intubation system comprising: a styletcomprising a handle, a control mechanism disposed on the handle, and aflexible shaft, the flexible shaft being coupled to the handle, whereinthe flexible shaft includes an articulating tip, the articulating tiphaving a round shape, and the flexible shaft having a continuousexterior surface, wherein the control mechanism is configured toarticulate the tip of the flexible tube; a laryngoscope comprising ablade, the blade having a first end and a second end, a handle, thehandle being coupled to the first end of the blade, an optical capturedevice, the optical capture device being coupled to the second end ofthe blade, and a display device, wherein the display device isconfigured to display an image captured by the optical capture device;and an endotracheal tube comprising a tube, the tube being hollow andhaving a first end and a second end and a sealing mechanism, the sealingmechanism being configured to seal an airway of the patient.

Another aspect is a stylet adapted for mounting an endotracheal tubecomprising: a handle; a control mechanism disposed on the handle; and atube, the tube comprising a proximal end, a distal end, and a pivotableportion therebetween; wherein the proximal end of the tube is coupled tothe handle, the distal end of the tube is configured to move about thepivotable portion of the tube, the control mechanism is configured tocontrol the movement of the distal end of the tube, and wherein thedistal end of the tube includes an orientation mark corresponding to adirection of movement of the distal end of the tube.

Another aspect is a method of positioning an endotracheal tube in apatient comprising: inserting a blade of a laryngoscope in a mouth ofthe patient; viewing a trachea of the patient on a display device of thelaryngoscope; mounting the endotracheal tube on an articulating stylet;inserting the stylet into an airway of the patient; viewing a tip of thestylet on the display device of the laryngoscope; articulating the tipof the stylet towards an entrance of the trachea; monitoring acontinuous distance marker on an exterior surface of the stylet;inserting the stylet further into the airway of the patient until thecontinuous distance marker indicate that the stylet is inserted to anappropriate depth; and sliding the endotracheal tube along the styletand into the trachea of the patient.

Another aspect is a method of positioning a stylet for placement of anendotracheal tube in a patient having a trachea, a pharynx, and vocalcords comprising: inserting a stylet into the pharynx, wherein thestylet comprises a handle, a tip, a target depth-assessment band, and ashallow depth-assessment band, and wherein the target depth-assessmentband and the shallow depth-assessment band are disposed near the tip;viewing the tip on a screen of a laryngoscope; determining whichdepth-assessment band is adjacent to the vocal cords; advancing thestylet if the shallow depth-assessment band is adjacent to the vocalcords; and not advancing the stylet if the target depth-assessment bandis adjacent to the vocal cords.

Another aspect is an endotracheal tube comprising: a hollow pipe, thehollow pipe having a proximal end and a distal end; wherein the distalend is configured to enter a trachea, and wherein the distal endincludes at least one depth-assessment band.

Another aspect is a stylet adapted for exchanging endotracheal tubescomprising: a tube, the tube comprising a proximal end and a distal end,wherein the distal end is configured to be inserted into a trachea of apatient through an endotracheal tube, and wherein the distal endincludes at least one depth-assessment band.

Another aspect is a method of replacing a first endotracheal tube with asecond endotracheal tube in a patient comprising: inserting a blade of alaryngoscope in a mouth of the patient; viewing a trachea of the patienton a display device of the laryngoscope; inserting a stylet into thefirst endotracheal tube, wherein the stylet comprises a proximal end anda distal end, the distal end including a tip; monitoring the position ofthe tip of the distal end of the stylet using a marker on an exteriorsurface of the stylet; advancing the stylet through the firstendotracheal tube until the tip of the distal end is inserted to anappropriate depth; removing the first endotracheal tube from an airwayof the patient, wherein the position of the tip of the distal end of thestylet is monitored while the first endotracheal tube is removed using amarker on an exterior surface of the stylet; placing the secondendotracheal tube over the proximal end of the stylet; and sliding thesecond endotracheal tube along the stylet and into the trachea of thepatient.

Another aspect is an articulating stylet adapted for exchangingendotracheal tubes comprising: a tube, the tube comprising a proximalend, a distal end, and a pivotable portion therebetween; wherein theproximal end of the tube is configured to move about the pivotableportion of the tube and the distal end of the tube is configured to moveabout the pivotable portion of the tube in response to movement of theproximal end of the tube, and wherein the distal end of the tubeincludes at least one depth-assessment band.

Yet another aspect is an articulating stylet system adapted forexchanging endotracheal tubes comprising: a stylet comprising a tube,the tube comprising a proximal end, a distal end, and a pivotableportion therebetween, wherein the proximal end of the tube is configuredto move about the pivotable portion of the tube and the distal end ofthe tube is configured to move about the pivotable portion of the tubein response to movement of the proximal end of the tube, and wherein thedistal end of the tube includes at least one depth-assessment band; anda handle, the handle configured to removably couple to the stylet.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of an example tracheal intubation system including alaryngoscope being used to intubate a patient.

FIG. 2 is a perspective view of an example laryngoscope.

FIG. 3 is a perspective view of an example articulating stylet.

FIG. 4 is a cross-sectional view of the articulating stylet of FIG. 3.

FIG. 5 is a perspective view of the tip of the articulating stylet ofFIG. 3.

FIG. 6 is a perspective view of an example endotracheal tube.

FIG. 7 is a flowchart of an example process of placing an endotrachealtube in a patient using an example tracheal intubation system includinga laryngoscope.

FIG. 8 is a cross-sectional view of a patient after a laryngoscope ispositioned to view the glottis during an intubation procedure using anexample tracheal intubation system including a laryngoscope.

FIG. 9 is a view of an example endotracheal tube mounted on an examplearticulating stylet.

FIG. 10 is a cross-sectional view of a patient after the tip of thearticulating stylet is advanced into the field of view of a laryngoscopeduring an intubation procedure using an example tracheal intubationsystem including a laryngoscope.

FIG. 11 is a cross-sectional view of a patient after the tip of anarticulating stylet is pivoted towards the glottis during an intubationprocedure using an example tracheal intubation system including alaryngoscope.

FIG. 12 is a cross-sectional view of a patient after the tip of anarticulating stylet is advanced into the trachea to a firstdepth-assessment band during an intubation procedure using an exampletracheal intubation system including a laryngoscope.

FIG. 13 is a cross-sectional view of a patient after the tip of anarticulating stylet is advanced into the trachea to a seconddepth-assessment band during an intubation procedure using an exampletracheal intubation system including a laryngoscope.

FIG. 14 is a cross-sectional view of a patient after an endotrachealtube is advanced over the articulating stylet into the field of view ofthe laryngoscope during an intubation procedure using an exampletracheal intubation system including a laryngoscope.

FIG. 15 is a cross-sectional view of a patient after an endotrachealtube is advanced over the articulating stylet towards the glottis duringan intubation procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 16 is a cross-sectional view of a patient after an endotrachealtube is advanced over the articulating stylet into a final position inthe trachea during an intubation procedure using an example trachealintubation system including a laryngoscope.

FIG. 17 is a schematic view of an embodiment of the endotracheal tube ofFIG. 6 disposed in the trachea of a patient.

FIG. 18 is another schematic view of an embodiment of the endotrachealtube of FIG. 6 disposed further into the trachea if a patient.

FIG. 19 is a perspective view of an example alternative embodiment of anarticulating stylet.

FIG. 20 is a cross-sectional view of a patient during an intubationprocedure using an embodiment of the articulating stylet of FIG. 19 inan example tracheal intubation system including a laryngoscope.

FIG. 21 is another cross-sectional view of a patient during anintubation procedure using an embodiment of the articulating stylet ofFIG. 19 in an example tracheal intubation system including alaryngoscope.

FIG. 22 is a cross-sectional view of a patient during an intubationprocedure using another embodiment of the articulating stylet of FIG. 19in an example tracheal intubation system including a laryngoscope.

FIG. 23 is another cross-sectional view of a patient during anintubation procedure using another embodiment of the articulating styletof FIG. 19 in an example tracheal intubation system including alaryngoscope.

FIG. 24 is a cross-sectional view of an embodiment of the articulatingstylet of FIG. 19.

FIG. 25 is a cross-sectional view of an embodiment of the shaft of thearticulating stylet of FIG. 19 at the location indicated in FIG. 24.

FIG. 26 is another cross-sectional view of the embodiment of the shaftof FIG. 25 at the location indicated in FIG. 24.

FIG. 27 is another cross-sectional view of an embodiment of the shaft ofFIG. 25 at the location indicated in FIG. 24.

FIG. 28 is another cross-sectional view of an embodiment of the shaft ofFIG. 25 at the location indicated in FIG. 24.

FIG. 29 is another cross-sectional view of an embodiment of the shaft ofFIG. 25 at the location indicated in FIG. 24.

FIG. 30 is a cross-sectional view of another embodiment of the shaft ofthe articulating stylet of FIG. 19 at the location indicated in FIG. 24.

FIG. 31 is another cross-sectional view of an embodiment of the shaft ofthe articulating stylet of FIG. 30 at the location indicated in FIG. 24.

FIG. 32 is another cross-sectional view of an embodiment of the shaft ofthe articulating stylet of FIG. 30 at the location indicated in FIG. 24.

FIG. 33 is another cross-sectional view of an embodiment of the shaft ofthe articulating stylet of FIG. 30 at the location indicated in FIG. 24.

FIG. 34 is another cross-sectional view of an embodiment of the shaft ofthe articulating stylet of FIG. 30 at the location indicated in FIG. 24.

FIG. 35 is a perspective view of an embodiment of a pyramidal-shapedarticulating disc of the articulating stylet of FIG. 19.

FIG. 36 is a side view of a structure of an embodiment of thearticulating stylet of FIG. 19.

FIG. 37 is a perspective view of an embodiment of a round-shapedarticulating disc of the articulating stylet of FIG. 19.

FIG. 38 is a side view of a structure of an embodiment of thearticulating stylet of FIG. 19.

FIG. 39 is a side view of an embodiment of the articulating stylet ofFIG. 19.

FIG. 40 is a side view of another embodiment of the articulating styletof FIG. 19.

FIG. 41 is a flowchart of an example endotracheal tube exchange processusing an embodiment of the articulating stylet of FIG. 19.

FIG. 42 is a cross-sectional view of a patient during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 43 is a cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 44 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 45 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 46 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 47 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope.

FIG. 48 is a perspective view of an embodiment of a removable handle forthe articulating stylet of FIG. 19.

FIG. 49 is a perspective view of the embodiment of the removable handleof FIG. 48 coupled to the articulating stylet of FIG. 19.

FIG. 50 is a side view of an embodiment of the articulating stylet ofFIG. 19.

DETAILED DESCRIPTION

Various embodiments will be described in detail with reference to thedrawings, wherein like reference numerals represent like parts andassemblies throughout the several views. Reference to variousembodiments does not limit the scope of the claims attached hereto.Additionally, any examples set forth in this specification are notintended to be limiting and merely set forth some of the many possibleembodiments for the appended claims.

The present disclosure relates generally to a tracheal intubation systemincluding a laryngoscope. This disclosure also relates to methods ofperforming tracheal intubation and endotracheal tube exchangeprocedures.

In some cases, the endotracheal tube of an intubated patient needs to beexchanged for a new endotracheal tube. One method for this exchangeprocess involves placing a catheter or stylet through the existingendotracheal tube until the tip of the catheter or stylet enters thetrachea. The existing endotracheal tube is then removed over thecatheter or stylet, while the catheter or stylet is left in place. A newendotracheal tube is then placed over the catheter or stylet. The newendotracheal tube is then advanced over the catheter or stylet until thetip of the new endotracheal tube is properly placed in the trachea. Thecatheter or stylet is then removed from the patient. The newendotracheal tube is then connected to an external ventilator orbreathing circuit. The ventilator is then able to breath for thepatient, delivering oxygen into the patient's lungs.

There are many potential complications that may arise duringendotracheal tube exchange procedures. For example, the tip of thecatheter or stylet can cause tracheal and lung trauma, which can causeharm or death to the patient. This is a possible complication. Poordepth control of the tip of the catheter or stylet during theendotracheal tube exchange procedure is a contributing factor in thistrauma to the trachea or lungs. An additional potential complication isthe accidental removal of the tip of the exchange catheter or styletfrom the trachea during the endotracheal tube exchange procedure. Thiscan lead to the new endotracheal tube not entering the trachea,resulting in a failed endotracheal intubation and harm or death to thepatient.

FIG. 1 is a diagram of an example tracheal intubation system 100including a laryngoscope being used to intubate a patient P. The exampleintubation system 100 includes a laryngoscope 102, an articulatingstylet 104, and an endotracheal tube 106. Also illustrated are the mouthM and the nose N of the patient P. In this example, the laryngoscope 102is inserted into the mouth M of the patient P, the articulating stylet104 is inserted into the nose N of the patient P, and the endotrachealtube 106 is mounted on the articulating stylet 104. In otherembodiments, the articulating stylet 104 is inserted into the mouth M ofthe patient P.

The patient P is a person or animal who is being intubated. Although theintubation system 100 is particularly useful to intubate a patient witha difficult airway, the intubation system 100 may also be used on apatient with a normal airway. Examples of patient P include adults,children, infants, elderly people, obese people, people with tumorsaffecting the head or neck, and people with unstable cervical spines. Insome embodiments, the intubation system 100 may be used to intubateanimals with normal or difficult airways. The intubation system 100 maybe used to intubate other people or animals as well.

The laryngoscope 102 is a medical instrument configured to permit acaregiver to directly or indirectly view, among other things, theglottis of the patient P. In some embodiments, the laryngoscope 102includes a blade with an integrated optical capture device and lightsource. In some embodiments, the blade is configured to be insertedthrough the mouth M of the patient P and positioned so that the glottisis in the field of view of the optical capture device. The imagecaptured by the laryngoscope 102 is viewed from a position that isexternal to the patient P. In some embodiments, the image captured bythe laryngoscope 102 is viewed on an external display device, such as ascreen. The laryngoscope 102 is illustrated and described in more detailwith reference to FIG. 2.

The articulating stylet 104 includes a thin, flexible tube that may bedirected and advanced into the airway of the patient P. The articulatingstylet 104 is configured to serve as a guide in the placement of theendotracheal tube 106. The articulating stylet 104 includes a handlewith a control mechanism that is configured to direct the tip of thearticulating stylet 104. The articulating stylet 104 is configured to beviewed with the laryngoscope 102 during the intubation procedure. Thearticulating stylet 104 is illustrated and described in more detail withreference to FIGS. 3-5.

In some embodiments, the endotracheal tube 106 is a hollow tube that isconfigured to be placed in the airway of the patient P. When the patientP is intubated, one end of the endotracheal tube 106 is disposed insidethe trachea of the patient P and the other end is connected to anexternal ventilator or breathing circuit. The endotracheal tube 106 isconfigured to occlude the airway of the patient P. Thus, gases (e.g.,room air, oxygenated gases, anesthetic gases, expired breath, etc.) mayflow into and out of the trachea of the patient P through theendotracheal tube 106. In some embodiments, the endotracheal tube 106may be connected to a breathing circuit, including for example amachine-powered ventilator or a hand-operated ventilator. In otherembodiments, the patient P may breathe through the endotracheal tube 106spontaneously. The endotracheal tube 106 is illustrated and described inmore detail with reference to FIG. 6.

The endotracheal tube 106 is configured to be mounted on thearticulating stylet 104 by sliding over the tip and along the shaft ofthe articulating stylet 104. After a caregiver has positioned the tip ofthe articulating stylet 104 in the trachea of the patient P, theendotracheal tube 106 is advanced over the shaft of the articulatingstylet 104 and into the trachea of the patient P. In this manner, thearticulating stylet 104 guides the endotracheal tube 106 into the properlocation in the trachea of the patient P. The process of positioning theendotracheal tube 106 is illustrated and described in more detail withreference to FIGS. 7-16.

FIG. 2 is a perspective view of an example of the laryngoscope 102. Insome embodiments, the laryngoscope 102 includes a blade 110, handle 112,and display device 114.

In some embodiments, the blade 110 is curved and has a first end 116 anda second end 118. The first end 116 is coupled to the handle 112. Thesecond end 118 is configured to be inserted through the mouth of thepatient and into the pharynx of the patient as illustrated and describedwith reference to FIG. 8. In some embodiments, the blade 110 isstraight. In some embodiments, the cross section of the blade 110 istrough-like, while in other embodiments the cross section of the blade110 is tubular. Yet other embodiments of the blade 110 are possible.

In some embodiments, the blade 110 includes an optical capture device120 and light source 122. In some embodiments, the optical capturedevice 120 and the light source 122 are disposed near the second end 118of the blade 110. Accordingly, when the blade 110 is inserted into thepharynx of the patient, the light source 122 illuminates the glottis ofthe patient and the optical capture device 120 captures an opticalrepresentation of the glottis of the patient, such as an image, a video,or light waves. In some embodiments, the blade 110 includes multipleoptical capture devices 120 and light sources 122.

The optical capture device 120 is a device for capturing images. In someembodiments, the optical capture device 120 is a camera or image capturesensor, such as a charge-coupled device or complementarymetal-oxide-semiconductor. In some embodiments, the optical capturedevice 120 is a digital video camera. In other embodiments, the opticalcapture device 120 is an optical fiber. In yet other embodiments, theoptical capture device 120 is a mirror. Yet other embodiments of theoptical capture device 120 are possible as well.

The light source 122 is a device that is configured to transmit ordirect light towards the glottis. In some embodiments, the light source122 is configured to generate light. In other embodiments, the lightsource 122 is configured to reflect light. Examples of the light source122 include light emitting diodes, incandescent bulbs, optical fibers,and mirrors. Other embodiments include other light sources.

The handle 112 is coupled to the first end 116 of the blade 110 and isconfigured to be held in a hand of a caregiver. The handle 112 operatesto receive inputs from a caregiver and to adjust the position andorientation of the blade 110, and accordingly to aim the optical capturedevice 120 contained at the second end 118 thereof.

In some embodiments, the handle 112 has a cylindrical shape. In someembodiments, the cross section of the handle 112 is rectangular. Inother embodiments, the cross section of the handle 112 is rectangularwith rounded corners. In some embodiments, the handle 112 includes oneor more molded finger grips. Other embodiments have other configurationsof handle 112.

The display device 114 is configured to display, among other things,videos, images, or light waves that are captured by the optical capturedevice 120. In some embodiments, the display device 114 includes ascreen 126. In some embodiments, the display device 114 is coupled tothe handle 112 with a cable 124. In other embodiments, the displaydevice 114 is formed integrally with the handle 112. In someembodiments, the display device 114 is a mirror. In some embodiments, asingle mirror operates as both the display device 114 and the opticalcapture device 120. Yet other embodiments of display device 114 arepossible.

In some embodiments, a cable 124 is disposed inside part or all of thehandle 112, the blade 110, or both. In some embodiments, the cable 124is configured to carry power to the optical capture device 120 and lightsource 122 and to carry electrical signals representing the video orimages generated by the optical capture device 120 to the display device114. In other embodiments, cable 124 is a fiber cable and operates tooptically transmit light waves captured by the optical capture device120 to the display device 114. Other embodiments do not include cable124. For example, in some embodiments, video or images captured by theoptical capture device 120 are transmitted wirelessly to the displaydevice 114. In yet other embodiments, images captured by the opticalcapture device 120 are transmitted with one or more mirrors.

In some embodiments, the screen 126 is a liquid crystal display. Inother embodiments, the screen 126 is a light-emitting diode display orcathode ray tube. In some embodiments, screen 126 is the surface of amirror. Still other embodiments of the screen 126 are possible as well.The screen 126 operates to receive a signal representing an image anddisplay that image.

Examples of the laryngoscope 102 include the GLIDESCOPE® videolaryngoscope, manufactured by Verathon Inc. of Bothell, Wash., theVIVIDTRAC VT-A100® video intubation device, manufactured by VividMedical Inc. of Palo Alto, Calif., and the C-MAC® video laryngoscope,manufactured by Karl Storz GmbH & Co. KG of Tuttlingen, Germany. Otherexamples of laryngoscope 102 include other video laryngoscopes,fiberoptic bronchoscopes, fiberoptic stylets, mirror laryngoscopes, andprism laryngoscopes. There are many other examples of the laryngoscope102 as well.

FIG. 3 is a perspective view of an example articulating stylet 104configured to guide an endotracheal tube into the trachea of a patient.The articulating stylet 104 includes a handle 130 and a shaft 134. Thehandle 130 includes a tip control mechanism 132.

In some embodiments, the handle is configured to be held in a hand of acaregiver. In some embodiments, the handle 130 has a shape that fitscomfortably in the hand of a caregiver. In some embodiments, the crosssection of the handle 130 is cylindrical. In some embodiments, the crosssection of the handle 130 is rectangular. In other embodiments, thecross section of the handle 130 is rectangular with rounded corners. Insome embodiments, the handle 130 includes one or more molded fingergrips.

The tip control mechanism 132 is configured to control the directionalmovement of the tip 138 of the shaft 134. In some embodiments, the tipcontrol mechanism 132 is configured to be manipulated by a thumb of acaregiver. In other embodiments, the tip control mechanism 132 isconfigured to be manipulated by one or more fingers or the palm of acaregiver.

In some embodiments, the tip control mechanism 132 is a switch that hasthree physical positions. Each physical position corresponds to amovement instruction for the tip 138. For example, one physical positioninstructs the tip 138 to move or pivot in a first direction, a secondphysical position instructs the tip 138 to move or pivot in a seconddirection, and a third physical position instructs the tip 138 to remainstationary. In other embodiments, the tip control mechanism 132 may havefewer or more than three physical positions.

In some embodiments, the tip control mechanism 132 is a potentiometerand behaves in a manner similar to a joystick. In these embodiments, thetip 138 is articulated in a first direction by actuating thepotentiometer in one direction and the tip 138 is articulated in asecond direction by actuating the potentiometer in another direction.Depending on the magnitude of actuation of the potentiometer, the tip138 may pivot to a greater or lesser degree. When the potentiometer isnot actuated, the tip 138 is not articulated. In other embodiments, thetip control mechanism 132 is implemented with one or more buttons ortouch sensors. When one of the buttons or touch sensors is activated,the tip 138 is articulated in a specific direction. In some embodiments,the tip control mechanism 132 is a wheel, trigger, or lever. Still otherembodiments of tip control mechanism 132 are possible.

The shaft 134 includes an exterior surface 136 and a tip 138. The shaft134 is configured to be inserted into the nose or mouth of a patient anddirected through the glottis of the patient and into the trachea of thepatient.

At an end opposite the tip 138, the shaft 134 is coupled to the handle130. In some embodiments, the shaft 134 is between two to three feet inlength and has a diameter of 3/16″ of an inch. In other embodiments,especially those directed towards pediatric patients, the shaft 134 hasa smaller diameter. Other embodiments, with smaller or greater lengthsor smaller or greater diameters are possible as well.

In some embodiments, the shaft 134 has a tubular shape and is formedfrom a flexible material that is configured to adapt to the shape of theairway of the patient. In some embodiments, the cross-section of theshaft 134 has an oblong shape. Other embodiments of shaft 134 with othershapes are possible.

In some embodiments, the exterior surface 136 comprises a single,continuous, uniform material. In some embodiments, the exterior surface136 has non-stick properties. For example, in some embodiments theexterior surface 136 is formed from polytetrafluoroethylene. In otherembodiments, the exterior surface 136 is configured to receive alubricant. Other embodiments of the exterior surface 136 are possible aswell. Because the exterior surface 136 is formed from a continuousmaterial, the exterior surface 136 does not have any seams. Accordingly,the exterior surface 136 can be quickly and inexpensively cleaned. Forexample, the exterior surface 136 may be sterilized without the use ofexpensive and time consuming sterilization equipment (e.g., anautoclave).

In some embodiments, the tip 138 is configured to move or pivotindependently from the remainder of shaft 134. In some embodiments, thetip 138 is configured to minimize trauma as it moves through the nose ormouth into the upper airway and advances into the trachea of thepatient. In some embodiments, the tip 138 is contained within theexterior surface 136. In some embodiments, the tip 138 has a bluntrounded shape. In some embodiments, the tip 138 does not have edges,corners, or crevices that may potentially injure the patient. Stillother embodiments of the tip 138 are possible.

In some embodiments the shaft 134 and tip 138 do not contain, and arefree of, a camera, light source, or other mechanism to illuminate orcapture images of the patient. Accordingly, in some embodiments thedesign of the exterior surface 136 of the shaft 134 and tip 138 isdesigned to reduce trauma and simplify sterilization. The design of theexterior surface 136 of the shaft 134 and tip 138 is not constrained bythe requirements of a camera, light source, or optical fibers, such aslenses, heating elements for defogging, and lumens for directing wateror suctioning to clear the field of view.

FIG. 4 is a cross-sectional view of an example of the articulatingstylet 104. The articulating stylet 104 includes a shaft 134 and ahandle 130. In some embodiments, the shaft 134 includes a first segment150, a second segment 152, a pivotable portion 154, a first cable 156,and a second cable 158, all of which are contained within the exteriorsurface 136. The handle 130 includes a tip control mechanism 132 andcable control mechanism 160.

The first segment 150 is coupled to the handle 130 on one end and thepivotable portion 154 on the other end. The first segment 150 iscontained within the exterior surface 136. In some embodiments, thefirst segment 150 is formed of a flexible material. In otherembodiments, the first segment 150 is formed from a semi-rigid material.In some embodiments, the first segment 150 is formed from a shape memorymaterial. In these examples, the first segment 150 has a bias towardsstraightening out and the flexibility to bend to adapt to the anatomy ofthe airway of the patient. In some embodiments, the first segment 150 isformed from a flexible spring. Yet other embodiments of first segment150 are possible as well.

The second segment 152 is coupled to the pivotable portion 154 on oneend and forms the tip 138 with the other end. The second segment 152 iscontained within the exterior surface 136. In some embodiments, thesecond segment 152 is formed from a rigid material, such as a metal,plastic, composite, or a combination thereof. In other embodiments,second segment 152 is formed from a rigid or semi-rigid material. Insome embodiments, second segment 152 is formed from the same material asfirst segment 150.

The pivotable portion 154 is coupled to the first segment 150 and thesecond segment 152. The pivotable portion 154 is configured to pivotabout one or more axes. In some embodiments, the pivotable portion 154is a hinge. In other embodiments, the pivotable portion 154 is a joint,such as a ball and socket joint. In yet other embodiments, some or allof the shaft 134 is formed from a spring and the pivotable portion 154is formed from a spring that is loosely wound relative to adjacentportions of the spring.

In some embodiments, the pivotable portion 154 is configured to allowsecond segment 152 to pivot about an axis between negative 90 degreesand positive 90 degrees. In other embodiments, pivotable portion 154 isconfigured to allow second segment 152 to pivot about an axis by more orfewer degrees.

In some embodiments, the pivotable portion 154 is configured to allowthe second segment 152 to pivot about an axis in a single plane. Inother embodiments, the pivotable portion 154 is configured to allow thesecond segment 152 to move about axes in multiple planes or even to movefreely in any direction. However, in other embodiments the shaft 134does not include the second segment 152, the pivotable portion 154, thefirst cable 156, and the second cable 158. Accordingly, in theseembodiments, the tip 138 does not articulate.

In some embodiments, the second segment 152 includes a first cableconnection point 162 and a second cable connection point 164. The firstcable connection point 162 and second cable connection point 164 aredisposed at or near the same distance longitudinally along the secondsegment 152 but on or near opposite sides radially of second segment152. In some embodiments, the first segment 150 includes a first eyelet166 and a second eyelet 168. In some embodiments, the first eyelet 166and the second eyelet 168 are circular apertures.

In some embodiments, one end of the first cable 156 is connected to thefirst cable connection point 162 and one end of the second cable 158 isconnected to the second cable connection point 164. The opposite ends ofthe first cable 156 and the second cable 158 are connected to the cablecontrol mechanism 160. In some embodiments, the first cable 156 passesthrough first eyelet 166 and the second cable 158 passes through thesecond eyelet 168.

In some embodiments, the cable control mechanism 160 operates in a firstmode, a second mode, and a third mode. In the first mode, the cablecontrol mechanism 160 pulls the first cable 156 and relaxes the secondcable 158 causing the second segment 152 to pivot in a direction D1. Inthe second mode, the cable control mechanism 160 relaxes the first cable156 and pulls the second cable 158 causing the second segment 152 topivot in a direction D2. In the third mode, the cable control mechanism160 neither pulls nor relaxes the first cable 156 and neither pulls norrelaxes the second cable 158 leaving the second segment 152 in itscurrent position. In some embodiments, tip control mechanism 132 isconfigured to select the mode of the cable control mechanism 160. Insome embodiments, there are more or fewer cables are there are more orfewer modes. Other embodiments use completely different methods ofmoving or pivoting the tip 138. For example, in some embodiments, amotor is disposed in the shaft 134 near the tip 138 to pivot the secondsegment 152.

Although the embodiment shown in FIG. 4 includes two segments and onepivotable portion, other embodiments with additional segments andpivotable portions are possible as well. In some of these embodiments,the shaft 134 also includes additional cables, cable connection points,and eyelets.

FIG. 5 is a perspective view of the tip 138 of an example articulatingstylet 104. The tip 138 includes an orientation mark 140 and one or moredepth-assessment bands 142 a-c (collectively depth-assessment bands142).

The orientation mark 140 is an indicator that is on or visible throughthe exterior surface 136 and is configured to be visible when thearticulating stylet 104 is viewed with the laryngoscope 102. Theorientation mark 140 is configured to convey information about theradial orientation of the articulating stylet 104. In some embodiments,the orientation mark 140 is a straight line the starts at or near theend of tip 138 and continues longitudinally along the length of shaft134. In some embodiments, the orientation mark 140 is present throughoutthe entire length of the shaft 134. In other embodiments, theorientation mark 140 is only present along a portion of the shaft 134.In some embodiments, the orientation mark 140 is radially aligned withthe direction D1, in which the tip 138 is configured to move. In thismanner, a caregiver is able to view the orientation mark 140 on thedisplay device of the laryngoscope 102 to determine the direction thetip 138 will move if it is pivoted. Thus, a caregiver is able to quicklydirect the articulating stylet 104 into the trachea of the patientwithout erroneously pivoting the tip 138, which may result in delay ortrauma to the patient.

In some embodiments, the orientation mark 140 is a dashed line or aseries of dots. In some embodiments, the orientation mark 140 is notradially aligned with the direction D1 but still conveys the orientationinformation necessary for a caregiver to direct the articulating stylet104. In some embodiments, multiple orientation marks are included. Yetother embodiments are possible as well.

In some embodiments, the articulating stylet 104 includes one or moredepth-assessment bands 142. In the embodiment shown in FIG. 5, thearticulating stylet 104 includes a first depth-assessment band 142 a,second depth-assessment band 142 b, and a third depth-assessment band142 c. The depth-assessment bands 142 are visual indicators that are onor visible through the exterior surface 136 and are configured to bevisible when the articulating stylet 104 is viewed with the laryngoscope102. The depth-assessment bands 142 are configured to convey informationabout the placement of the articulating stylet 104 relative to theanatomical landmarks of the patient, such as the vocal cords, that arealso visible through the laryngoscope 102. The depth-assessment bands142 are also configured to convey information about the longitudinaldistance to the end of the tip 138.

Adjacent depth-assessment bands 142 are visually distinct from eachother so that a caregiver who views a part of one of thedepth-assessment bands 142 from the laryngoscope is able to identifyspecifically which of the depth-assessment bands 142 is in the field ofview. Because the depth-assessment bands 142 are continuous regions, itis not necessary for a caregiver to advance or retract the articulatingstylet 104 to bring one of the depth-assessment bands 142 into the fieldof view of the laryngoscope 102, which would create a risk of trauma tothe patient or inadvertent removal of the articulating stylet 104 fromthe trachea of the patient. Nor does a caregiver need to remember orcount the depth-assessment bands 142 as they pass through the field ofview. In this manner, the depth-assessment bands 142 minimize trauma tothe patient and allow a caregiver to focus on using the articulatingstylet 104 rather than counting depth-assessment bands 142. Further,using the depth-assessment bands 142 in this manner may reduce the timenecessary to complete a tracheal intubation procedure.

In some embodiments, the depth-assessment bands 142 are continuousregions of color that extend along a portion of the length of the shaft134. For example, the first depth-assessment band 142 a is a firstcolor, the second depth-assessment band 142 b is a second color, and thethird depth-assessment band 142 c is a third color. In otherembodiments, the depth-assessment bands 142 are continuous regions ofvisually distinct patterns rather than colors. In some embodiments, thedepth-assessment bands 142 include both visually distinct patterns andcolors. Yet other embodiments are possible as well.

In some embodiments, the lengths of the depth-assessment bands 142 areselected based on the clinical precision required for the intubationprocedure in which the articulating stylet 104 is intended and thedistance into the trachea of the patient a caregiver wishes to insertthe tip 138. For example, a caregiver may wish to insert the tip 138 twoto four centimeters into the trachea of an adult patient. In someembodiments for adult patients, the length of each of thedepth-assessment bands 142 is two centimeters. In this manner, thecaregiver will know that the tip 138 is properly inserted into thetrachea of the patient when any part of the second depth-assessment band142 b is aligned with the entrance of the trachea of an adult patient(i.e., the patient's vocal cords).

Similarly, in some embodiments for pediatric patients, the lengths ofthe depth-assessment bands 142 are adapted to the shorter tracheas ofthose pediatric patients. For example, a caregiver may wish to insertthe tip 138 one to two centimeters into the trachea of the pediatricpatient. In some embodiments for pediatric patients, the length of eachdepth-assessment band 142 is one centimeter. In this manner, thecaregiver will know that the tip 138 is properly inserted into thetrachea of the patient when any part of the second depth-assessment band142 b is aligned with the entrance of the trachea of the a pediatricpatient (i.e., the patient's vocal cords).

In some embodiments, the colors of the depth-assessment bands 142 conveyinformation about whether the tip 138 is properly positioned. In someexample embodiments, the first depth-assessment band 142 a is yellow,the second depth-assessment band 142 b is green, and the thirddepth-assessment band 142 c is red. The yellow color of the firstdepth-assessment band 142 a may convey to a caregiver to use caution inadvancing the tip 138 because it is not yet properly positioned. Thegreen color of the second depth-assessment band 142 b may convey successto a caregiver because the tip 138 appears to be properly positioned.The red color of the third depth-assessment band 142 c may conveywarning to a caregiver because the tip 138 may be positioned too deeplyin the trachea of the patient, potentially causing trauma.

Although the embodiment shown in FIG. 5 includes three depth-assessmentbands 142, other embodiments that include fewer or more depth-assessmentbands 142 are possible as well. In some embodiments, thedepth-assessment bands 142 are uniform in length. In other embodiments,one or more of the depth-assessment bands 142 has a different lengththan the other depth-assessment bands 142. For example, in applicationsrequiring great precision, one of the depth-assessment bands 142 isshorter in length than the other depth-assessment bands 142.Accordingly, when that one of the depth-assessment bands 142 is alignedwith the entrance to the trachea of a patient (i.e., the vocal cords), acaregiver is able to determine the depth of the tip 138 with greaterprecision.

Although the embodiment of the depth-assessment bands 142 shown in FIG.5 relates to an articulating stylet 104, the depth-assessment bands 142can also be used with other stylets. For example, in some embodiments,the depth-assessment bands 142 are used with a stylet that does notarticulate. In these embodiments, the stylet is similar to thearticulating stylet 104 described herein, except that the tip does notarticulate and the components that control the tip are not included. Inthese embodiments, the stylet still includes the depth-assessment bands142, which can be viewed with the laryngoscope 102 to determine theposition of the non-articulating tip of the stylet relative to variousanatomical landmarks.

Although the embodiments described herein relate to placement of anendotracheal tube, the depth-assessment bands are not limited to use inairway devices. In some embodiments, the depth-assessment bands 142 areincluded on other medical devices to guide the proper placement of thosemedical devices as well. For example, in some embodiments, thedepth-assessment bands 142 are included in central venous catheters,endoscopic devices, devices placed in the gastrointestinal tract,devices placed inside the cardiovascular system, devices placed insidethe urinary system, devices placed inside of the ears, devices placedinside of the eyes, devices placed in the central nervous system,devices placed inside of the abdomen, devices placed inside the chest,or devices placed inside the musculoskeletal system. In theseembodiments, the depth-assessment bands 142 are configured to becompared to various. In these embodiments, the depth-assessment bands142 are configured to convey information about the placement of thedevice relative to various anatomical landmarks compared to other organsystems inside the body or even outside of the body. Additionally, insome embodiments, the depth-assessment bands 142 are included onnon-medical devices in which depth control is desired. For example, thedepth-assessment bands 142 can be included in industrial devices, suchas devices for the inspection of machinery or physical structures, anddevices for the proper placement of fasteners or other industrial orphysical parts.

FIG. 6 is a perspective view of an example endotracheal tube 106. Theendotracheal tube 106 includes a pipe 170, a cuff 172, and an inflationlumen 174. In some embodiments, the endotracheal tube 106 does notinclude the cuff 172 or the inflation lumen 174.

In some embodiments, the pipe 170 is hollow and includes a first end178, a second end 180, and an exterior surface 182. In some embodiments,the pipe 170 is formed from a flexible material and operates to adapt tothe anatomy of the patient. For example, in some embodiments, the pipe170 is formed from polyvinyl chloride. In other embodiments, the pipe170 is formed from silicone rubber or latex rubber. In some embodiments,the pipe 170 is formed from a rigid or semi-rigid material, such asstainless steel.

The pipe 170 operates as a passage for gases to enter and exit thetrachea of the patient. The pipe 170 also operates to protect the lungsof the patient from stomach contents. Further, in some embodiments, thepipe 170 operates as a passage to suction the trachea and lungs of thepatient. The first end 178 is configured to be advanced into the tracheaof the patient. The second end 180 is configured to be connected to aventilator or breathing circuit.

In some embodiments, the cuff 172 is disposed on the exterior surface182 of the pipe 170 near the first end 178. The cuff 172 is configuredto form a seal between the exterior surface 182 of the pipe 170 and thetrachea of the patient. In this manner, the cuff 172 prevents gases andliquids from entering or exiting the trachea of the patient withoutpassing through the pipe 170. In addition, the cuff 172 secures theposition of the endotracheal tube 106 in the trachea of the patient. Insome embodiments, the cuff 172 is an inflatable chamber. For example, insome embodiments, the cuff 172 is a balloon. Yet other embodiments ofthe cuff 172 are possible as well.

The inflation lumen 174 includes an inflation port 176. The inflationlumen 174 is connected to the cuff 172 and operates as a channel for theentry of fluid into the cuff 172. The inflation port 176 is configuredto receive a fluid. In some embodiments, the inflation port 176 isconfigured to receive a syringe that operates to expel fluid through theinflation lumen 174 and into the cuff 172. In this manner, the cuff 172can be inflated to seal the trachea of the patient.

In some embodiments, the endotracheal tube 106 is formed from atransparent or translucent material that allows the articulating stylet104 to be seen therethrough. In some embodiments, the endotracheal tube106 includes one or more depth-assessment bands 184 a-c (collectivelydepth-assessment bands 184). In the embodiment shown in FIG. 6, theexample endotracheal tube 106 includes a first depth-assessment band 184a, second depth-assessment band 184 b, and a third depth-assessment band184 c. The depth-assessment bands 184 are indicators that are on orvisible through the exterior surface 182 and are configured to bevisible when the articulating stylet 104 is viewed with the laryngoscope102. The depth-assessment bands 184 are configured to convey informationabout the placement of the endotracheal tube 106 relative to theanatomical landmarks of the patient, such as the vocal cords, that arealso visible through the laryngoscope 102. The depth-assessment bands184 are also configured to convey information about the longitudinaldistance to the end of the first end 178.

Adjacent depth-assessment bands 184 are visually distinct from eachother so that a caregiver who views a part of one of thedepth-assessment bands 184 from the laryngoscope 102 is able to identifywhich specific one of the depth-assessment bands 184 is in the field ofview. Because the depth-assessment bands 184 are continuous regions, itis not necessary for a caregiver to advance or retract the endotrachealtube 106 to bring the depth-assessment bands 184 into the field of viewof the laryngoscope 102, which would create a risk of trauma to thepatient or inadvertent removal of the endotracheal tube 106 from thetrachea of the patient. Nor does a caregiver need to remember or countthe depth-assessment bands 184 as they pass through the field of view.In this manner, the depth-assessment bands 184, minimize trauma to thepatient and allow a caregiver to focus on advancing the endotrachealtube 106 rather than counting depth-assessment bands 184. Further, usingthe depth-assessment bands 184, in this manner may reduce the timenecessary to complete a tracheal intubation procedure.

In some embodiments, the depth-assessment bands 184 are continuousregions of color that extend along a portion of the length of the pipe170. For example, the first depth-assessment band 184 a is a firstcolor, the second depth-assessment band 184 b is a second color, and thethird depth-assessment band 184 c is a third color. In otherembodiments, the depth-assessment bands 184 are continuous regions ofvisually distinct patterns rather than colors. In some embodiments, thedepth-assessment bands 184 include both visually distinct patterns andcolors. In addition, in some embodiments, one or more of thedepth-assessment bands 184 may include part or all of cuff 172. Yetother embodiments of the depth-assessment bands 184 are possible aswell.

In some embodiments, the lengths of the depth-assessment bands 184 areselected based on the clinical precision required for the intubationprocedure in which the endotracheal tube 106 is intended and thedistance into the trachea of the patient a caregiver wishes to insertthe first end 178. For example, a caregiver may wish to insert the firstend 178 two to four centimeters into the trachea of an adult patient. Insome embodiments for adult patients, the length of each of thedepth-assessment bands 184 is two centimeters. In this manner, thecaregiver will know that the first end 178 is properly inserted into thetrachea of the patient when any part of the second depth-assessment band184 b is aligned with the entrance of the trachea of an adult patient(i.e., the patient's vocal cords).

Similarly, in some embodiments for pediatric patients, the lengths ofthe depth-assessment bands 184 are adapted to the shorter tracheas ofthose pediatric patients. For example, a caregiver may wish to insertthe first end 178 one to two centimeters into the trachea of thepediatric patient. In some embodiments for pediatric patients, thelength of each of the depth-assessment bands 184 is one centimeter. Inthis manner, the caregiver will know that the first end 178 is properlyinserted into the trachea of the patient when any part of the seconddepth-assessment band 184 b is aligned with the entrance of the tracheaof the a pediatric patient (i.e., the patient's vocal cords).

In some embodiments, the colors of the depth-assessment bands 184 conveyinformation about whether the first end 178 is properly positioned. Insome example embodiments, the first depth-assessment band 184 a isyellow, the second depth-assessment band 184 b is green, and the thirddepth-assessment band 184 c is red. The yellow color of the firstdepth-assessment band 184 a may convey to a caregiver to use caution inadvancing the first end 178 because it is not yet properly positioned.The green color of the second depth-assessment band 184 b may conveysuccess to a caregiver because the first end 178 appears to be properlypositioned. The red color of the third depth-assessment band 184 c mayconvey warning to a caregiver because the first end 178 may bepositioned too deeply in the trachea of the patient, potentially causingtrauma.

Although the embodiment shown in FIG. 6 includes three depth-assessmentbands 184, other embodiments that include fewer or more depth-assessmentbands 184 are possible as well. In some embodiments, thedepth-assessment bands 184 are uniform in length. In other embodiments,one or more of the depth-assessment bands 184 has a different lengththan the other depth-assessment bands 184. For example, in applicationsrequiring great precision, one of the depth-assessment bands 184 isshorter in length than the other depth-assessment bands 184.Accordingly, when that one of the depth-assessment bands 184 is alignedwith the entrance to the trachea of a patient (i.e., the vocal cords), acaregiver is able to determine the depth of the first end 178 withgreater precision.

FIG. 7 is a flowchart of an example process of positioning anendotracheal tube in a patient using an example tracheal intubationsystem including a laryngoscope. In some embodiments, the articulatingstylet includes a handle, a flexible shaft, and a blunt, rounded tipthat is directed by a control mechanism on the handle.

Initially, at step 700, the laryngoscope is positioned to view theglottis of the patient. In some embodiments, the laryngoscope isinserted through the mouth of the patient. In other embodiments, thelaryngoscope is inserted through the nose of the patient. A caregiver,usually a physician or a person assisting a physician, grips the handleof the laryngoscope and maneuvers the handle to position the blade sothat the optical capture device of the laryngoscope has a clear view ofthe glottis of the patient. In some embodiments, the caregiver verifiesthat the laryngoscope is properly positioned by checking the screen ofthe display device of the laryngoscope. The field of view of thelaryngoscope is best seen in FIG. 8.

At operation 705, the endotracheal tube is mounted on the articulatingstylet. The endotracheal tube is mounted by placing the second end ofthe endotracheal tube over the tip of the articulating stylet andsliding the tube up the shaft of the articulating stylet. This operationmay be performed by the physician, someone assisting the physician, orsomeone preparing the equipment in advance. An example of anarticulating stylet with an endotracheal tube mounted is shown in FIG.9.

At operation 710, the tip of the articulating stylet is positioned inthe pharynx of the patient and is advanced until the tip is visible onthe screen of the laryngoscope. In some embodiments, the tip of thearticulating stylet is inserted through the nose of the patient. Inother embodiments, depending on the anatomy of the patient, the tip ofthe articulating stylet is inserted through the mouth of the patient. Anexample embodiment of an articulating stylet that is visible in thefield of view of the laryngoscope is shown in FIG. 10.

At operation 715, the tip of the articulating stylet is pivoted towardsthe entrance to the trachea of the patient. That is, the tip is pivotedso that when the articulating stylet is advanced, the tip will passbetween the vocal cords of the patient and into the trachea of thepatient. In some embodiments, a caregiver, usually a physician or personassisting a physician, pivots the tip of the articulating stylet using atip control mechanism. The caregiver pivots the tip of the articulatingstylet while viewing the tip on the screen of the laryngoscope. In someembodiments, the caregiver will observe an orientation mark on the shaftof the articulating stylet to determine the orientation of the styletrelative to the anatomy of the patient before using the tip controlmechanism to pivot the tip. In this manner, a caregiver is able todetermine the direction the tip will pivot prior to actually pivotingthe tip. An example embodiment of the articulating stylet with the tippivoted towards the entrance of the trachea of the patient is shown inFIG. 11.

At operation 720, the articulating stylet is advanced into the tracheaof the patient. In some embodiments, a caregiver, usually a physician ora person assisting a physician, advances the articulating stylet byholding the handle of the articulating stylet and slowly pushing theshaft of the articulating stylet into the mouth or nose of the patient.In some embodiments, where the patient is an adult, the caregiver willadvance the articulating stylet through the trachea of the patient byapproximately three centimeters. In other embodiments, the caregiverwill advance the stylet through the trachea of the patient by a smalleror larger distance. To accomplish this, the caregiver watches the tip ofthe articulating stylet with the laryngoscope.

In some embodiments, the articulating stylet includes one or moredepth-assessment bands. The caregiver views the shaft of thearticulating stylet on the screen of the laryngoscope to determine whichdepth-assessment band is adjacent to the vocal cords of the patient.Depending on which depth-assessment band is adjacent to the vocal cords,the caregiver may continue to advance the articulating stylet or stopadvancing the articulating stylet.

For example, in an embodiment in which the articulating stylet includesthree depth-assessment bands and the second depth-assessment bandrepresents the target insertion depth, a caregiver will continue toadvance the articulating stylet until the second depth-assessment bandis adjacent to the vocal cords of the patient. Accordingly, if thescreen of the laryngoscope shows that the first depth-assessment band isadjacent to the vocal cords, the caregiver may continue to advance thearticulating stylet. Similarly, if the screen of the laryngoscope showsthat the second depth-assessment band is adjacent to the vocal cords ofthe patient, the caregiver may determine that the tip of thearticulating stylet is properly positioned and, accordingly, will stopadvancing the articulating stylet. Finally, if the screen of thelaryngoscope shows that the third depth-assessment band is adjacent tothe vocal cords of the patient, the caregiver may determine that the tipof the articulating stylet has been advanced too far and will stopadvancing the articulating stylet or, in some cases, will retract thearticulating stylet. An example embodiment of the articulating styletwith three depth-assessment bands being advanced into the trachea of thepatient is shown in FIGS. 12 and 13.

At operation 725, the endotracheal tube is advanced over the shaft ofthe articulating stylet. In some embodiments, a caregiver, usually aphysician or person assisting a physician, grabs the endotracheal tubeand slides it along the articulating stylet until the first end of theendotracheal tube enters the trachea of the patient. An exampleembodiment of the endotracheal tube being advanced over the shaft of thearticulating stylet is shown in FIGS. 14 and 15.

At operation 730, the cuff of the endotracheal tube is inflated. In someembodiments, a caregiver, usually a physician or person assisting aphysician, inserts a fluid into the inflation port of the endotrachealtube. This causes the inflation cuff to expand and secures theendotracheal tube in the trachea of the patient. In addition, theinflation cuff seals the trachea of the patient so that gases will notflow around the endotracheal tube. Further, the inflation cuff seals thetrachea of the patient so that liquids, such as the contents of thestomach of the patient, will not enter the trachea and the lungs of thepatient. An example embodiment of an endotracheal tube with an inflatedcuff is shown in FIG. 16. In embodiments where the endotracheal tubedoes not include a cuff, this operation 730 is not performed.

At operation 735, the articulating stylet and laryngoscope are removed.The shaft of the articulating stylet is pulled out of the endotrachealtube, leaving the endotracheal tube in place. In addition, thelaryngoscope is also removed from the patient. The laryngoscope isremoved by grabbing the handle and pulling the blade out of the pharynxof the patient.

At operation 740, the endotracheal tube is connected to a ventilator orbreathing circuit to provide ventilation for the patient. In someembodiments, the endotracheal tube is connected to the ventilator orbreathing circuit before the laryngoscope is removed.

FIG. 8 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope.

The mouth M and nose N of the patient P are shown. The blade 110 of thelaryngoscope 102 is disposed in the pharynx of the patient P. The blade110 is oriented so that the field of view 50 of the optical capturedevice on blade 110 includes the vocal cords V and trachea T of thepatient P. Screen 126 shows the contents of the field of view 50 of theoptical capture device in the laryngoscope 102.

The screen 126 displays an image of the trachea T. The entrance to thetrachea T is defined by the vocal cords V1 and V2 (collectively vocalcords V). The vocal cords V meet at the arytenoids A. The esophagus E isbelow the trachea T and parallel to the trachea T. It is important thatthe blade 110 of the laryngoscope 102 is oriented so that screen 126shows a clear image of the entrance of the trachea T because thearticulating stylet will be directed into the trachea T.

FIG. 9 is a view of an example of an endotracheal tube 106 mounted on anarticulating stylet 104. As described in FIG. 6, the endotracheal tube106 includes a pipe with a first end 178 and a second end 180. The shaft134 of the articulating stylet 104 passes through the endotracheal tube106. The endotracheal tube 106 is oriented so that the first end 178 isnearer to the tip 138 of the articulating stylet 104 and the second end180 is nearer to the handle 130 of the articulating stylet 104.

FIG. 10 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The shaft 134 of the articulating stylet 104 is beingadvanced into the patient P through the nose N of the patient P. The tip138 is in the field of view of the optical capture device of thelaryngoscope 102. The first depth-assessment band 142 a and the seconddepth-assessment band 142 b are visible on screen 126. Screen 126displays that the tip 138 is currently directed towards the esophagus E.

FIG. 11 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The tip 138 of the articulating stylet 104 is pivoted upas compared to its position in FIG. 10. The screen 126 shows that thetip 138 is now directed towards the entrance of the trachea T.

FIG. 12 cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The tip 138 of the articulating stylet 104 is advancedinto the trachea T of the patient P. The screen 126 shows that the firstdepth-assessment band 142 a is adjacent to the vocal cords V.Accordingly, a caregiver may determine that the tip 138 needs to beadvanced further into the trachea T.

FIG. 13 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The tip 138 of the articulating stylet 104 is advancedfurther into the trachea T of the patient P as compared to FIG. 12. Thescreen 126 shows that the second depth-assessment band 142 b is nowadjacent to the vocal cords V. Accordingly, a caregiver may determinethat the tip 138 is properly positioned and does not need to be advancedfurther into the trachea T.

FIG. 14 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The tip 138 of the articulating stylet 104 is properlypositioned in the trachea T of the patient P. The endotracheal tube 106has been advanced over the shaft 134 of the articulating stylet 104. Theendotracheal tube 106 is guided by the articulating stylet 104 throughthe nose N of the patient P and into the pharynx of the patient P. Thefirst end 178 and the first depth-assessment band 184 a of endotrachealtube 106 are visible on the screen 126.

FIG. 15 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The tip 138 of the articulating stylet 104 is properlypositioned in the trachea T of the patient P. The endotracheal tube 106has been advanced further along shaft 134 of the articulating stylet 104as compared to FIG. 14. The endotracheal tube 106 is guided into thetrachea T of the patient P by the articulating stylet 104. The screen126 displays that the first end 178 of endotracheal tube 106 has not yetreached the vocal cords V. Both the first depth-assessment band 184 aand the second depth-assessment band 184 b are visible on screen 125.But neither the first depth-assessment band 184 a nor the seconddepth-assessment band 184 b are adjacent to the vocal cords V yet.Accordingly, the caregiver may determine that the first end 178 of theendotracheal tube 106 needs to be advanced further to enter the tracheaT of the patient P.

FIG. 16 is cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The endotracheal tube 106 has been advanced further alongshaft 134 of the articulating stylet 104 as compared to FIG. 15. Thescreen 126 displays that the endotracheal tube 106 has entered thetrachea T. Additionally, screen 126 displays that the seconddepth-assessment band 184 b is adjacent to the vocal cords V.Accordingly, a caretaker may determine that the endotracheal tube 106has been guided into the trachea T of the patient P and has beenproperly positioned therein. If instead the first depth-assessment band184 a were adjacent to the vocal cords V, a caregiver may determine thatthe endotracheal tube 106 needs to be advanced further into the tracheaT of the patient P. Conversely, if instead the third depth-assessmentband 184 c were adjacent to the vocal cords V, the caregiver mightdetermine that the endotracheal tube 106 was advanced too far into thetrachea T of the patient P. Once the endotracheal tube 106 is properlypositioned, the cuff 172 is inflated to seal the trachea T and securethe endotracheal tube 106 in position.

FIG. 17 is a schematic view of an embodiment of the endotracheal tube106 disposed in a trachea T. The diagram illustrates the vocal cords Vthat form the entrance to the trachea T and the left bronchus B1 and theright bronchus B2 that split off from the bottom of the trachea T. Theexample endotracheal tube 106 includes a first end 178, a firstdepth-assessment band 184 a, a second depth-assessment band 184 b, and athird depth-assessment band 184 c. In the figure, the seconddepth-assessment band 184 b is adjacent to the vocal cords V and thefirst end 178 is disposed in the middle of the trachea T. Here, acaretaker may determine that the endotracheal tube 106 is properlypositioned in the trachea T. Accordingly, by viewing the vocal cords Vand the second depth-assessment band 184 b with a laryngoscope, acaretaker is able to determine whether the endotracheal tube 106 isproperly positioned.

FIG. 18 is another schematic view of an embodiment of the endotrachealtube 106 disposed in a trachea T. Here, the endotracheal tube 106 hasbeen advance further into the trachea T relative to its position in FIG.17. In the figure, the third depth-assessment band 184 c is adjacent tothe vocal cords V and the first end 178 has begun to enter the leftbronchus B1. Here, the endotracheal tube 106 may cause trauma to theleft bronchus B1. Accordingly, by viewing the vocal cords V and thethird depth-assessment band 184 c with a laryngoscope, a caretaker isable to determine whether the endotracheal tube 106 is positioned toodeeply in the trachea T.

FIG. 19 is a perspective view of an example alternative embodiment of anarticulating stylet 800. The articulating stylet 800 is configured toguide an endotracheal tube into the trachea of a patient. In someembodiments, the articulating stylet 800 is configured to be used duringan endotracheal tube exchange procedure in which an existingendotracheal tube is replaced with a new endotracheal tube. In someembodiments, the articulating stylet 800 includes a shaft 804 and tipcontrol lever 802. However, in other embodiments, the articulatingstylet 800 does not include the tip control lever 802.

The shaft 804 includes an exterior surface 806 and a tip 808. In someembodiments, the shaft 804, the exterior surface 806, and the tip 808are similar to the shaft 134, the exterior surface 136, and the tip 138respectively, which are all shown and described in greater detail withrespect to FIG. 3. In some embodiments, the tip 808 is configured toarticulate. In other embodiments, the tip 808 does not articulate.

The tip control lever 802 is an elongate member and is configured tocontrol the directional movement of the tip 808. In some embodiments,the tip control lever 802 is configured to be actuated in one or moredirections by a caregiver. Upon actuation in a first direction, the tipcontrol lever 802 causes the tip 808 to articulate in a correspondingdirection. In some embodiments, the tip control lever 802 causes the tip808 to move in a direction that is substantially similar to thedirection in which the tip control lever 802 is actuated. In otherembodiments, the tip control lever 802 causes the tip 808 to move in adirection that is substantially opposite to the direction in which thetip control lever 802 is actuated. In some embodiments, the tip controllever 802 is rigid and actuates substantially in a rotational manneraround a single end point. In other embodiments, the tip control lever802 is flexible and is configured to be bent in one or more directions.

Additionally, in some embodiments, the tip control lever 802 is narrowenough that the endotracheal tube 106 may be advanced over it. If anexisting endotracheal tube 106 is already positioned in the trachea T ofthe patient P, the articulating stylet 800 may be advanced into thetrachea T of the patient P through that endotracheal tube 106. Then theendotracheal tube 106 may be removed by advancing the endotracheal tube106 along the articulating stylet 800, over the tip control lever 802,and off of the articulating stylet 800. Further, after the articulatingstylet 800 is positioned in the trachea T of the patient P, a newendotracheal tube 106 may be placed over the end of the tip controllever 802 and advanced along the articulating stylet 800. In thismanner, the articulating stylet 800 can be used to perform anendotracheal tube exchange procedure in which an existing firstendotracheal tube is removed and a new second endotracheal tube isinserted.

FIG. 20 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The example tracheal intubation system including alaryngoscope also includes the articulating stylet 800. In the exampleshown, the tip control lever 802 is rigid and is rotated into a positionLP1. Correspondingly, the tip 808 is articulated into a position TP1.

FIG. 21 is another cross-sectional view of a patient P during anintubation procedure using an example tracheal intubation systemincluding a laryngoscope. The example tracheal intubation systemincluding a laryngoscope also includes the articulating stylet 800. Inthis example, the tip control lever 802 is rigid and is rotated into aposition LP2. Correspondingly, the tip 808 is articulated into aposition TP2.

FIG. 22 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The example tracheal intubation system including alaryngoscope also includes the articulating stylet 800. In the exampleshown, the tip control lever 802 is flexible and is bent into a positionLP3. Correspondingly, the tip 808 is articulated into a position TP1.

FIG. 23 is a cross-sectional view of a patient P during an intubationprocedure using an example tracheal intubation system including alaryngoscope. The example tracheal intubation system including alaryngoscope also includes the articulating stylet 800. In the exampleshown, the tip control lever 802 is flexible and is bent into a positionLP4. Correspondingly, the tip 808 is articulated into a position TP2.

FIG. 24 is a cross-sectional view of an embodiment of the articulatingstylet 800. In FIG. 24, the articulating stylet 800 is in a straightposition. The articulating stylet 800 includes the tip control lever802, the shaft 804, the tip 808, a first cable 812, and a second cable814.

The tip control lever 802 includes a plurality of articulating discs816. Although in the embodiment shown, the tip control lever 802includes eight articulating discs 816, in other embodiments, the tipcontrol lever 802 includes more or fewer articulating discs 816.Similarly, the tip 808 also includes a plurality of articulating discs818. Although in the embodiment shown, the tip 808 includes eightarticulating discs 816, in other embodiments, the tip 808 includes moreor fewer articulating discs 818.

The articulating discs in the plurality of articulating discs 816 rotateor articulate against one another and allow the tip control lever 802 tobend or flex. Similarly, the articulating discs in the plurality ofarticulating discs 818 also rotate or articulate against one another andallow the tip 808 to bend or flex. Example embodiments of thearticulating discs of the pluralities of articulating discs 816 and 818are illustrated and described in greater detail with respect to FIGS.35-38. In some embodiments, at least a portion of the articulating discsin the pluralities of articulating discs 816 and 818 are pyramidalshaped as are shown in FIGS. 35-36. In some embodiments, at least aportion of the articulating discs in the pluralities of articulatingdiscs 816 and 818 are round shaped as are shown in FIGS. 37-38. In otherembodiments, at least a portion of the articulating discs in thepluralities of articulating discs 816 and 818 are other shapes. Further,in some embodiments, the articulating discs in the plurality ofarticulating discs 816 have a different shape than the articulatingdiscs in the plurality of articulating discs 818. Yet other embodimentsare possible as well.

The first cable 812 and the second cable 814 are cables or wires and areconfigured to control the movement of the tip 808. The first cable 812is secured to the tip control lever 802 and the tip 808. Similarly, thesecond cable 814 is also secured to the tip control lever 802 and thetip 808. The first cable 812 and the second cable 814 connected to thetip control lever 802 and the tip 808 at the same distancelongitudinally along the tip control lever 802 and the tip 808 but on ornear opposite sides radially of the tip control lever 802 and the tip808. Both the first cable 812 and the second cable 814 are threadedthrough the shaft 804 and at least a portion of the articulating discsin the pluralities of articulating discs 816 and 818. In someembodiments, the first cable 812 and the second cable 814 cross in theshaft 804. In other embodiments, the first cable 812 and the secondcable 814 do not cross in the shaft 804. Various embodiments of theshaft 804 and configurations of the cables are shown in FIGS. 25-34.

FIG. 25 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In the embodiment shown, the shaft804 includes a lumen 830, a first cable route 832, and a second cableroute 834.

The lumen 830 is pathway formed in the middle of the shaft 804. In someembodiments, the lumen 830 is used as a passageway between the tipcontrol lever 802 and the tip 808 for oxygen or other gasses. However,some embodiments do not include a lumen 830. In those embodiments, theshaft 804 is solid.

In some embodiments, the first cable route 832 and the second cableroute 834 are holes in the shaft 804 throughwhich the first cable 812and the second cable 814, respectively, are routed. In some embodimentsof the shaft 804 that include a lumen 830, the first cable route 832 andthe second cable route 834 are holes disposed in a wall structure of theshaft 804. Other embodiments of the first cable route 832 and the secondcable route 834 are possible as well.

In FIG. 25, the first cable route 832 is disposed in the shaft 804 inthe direction of D1 and the second cable route 834 is disposed in theshaft 804 in the direction of D3.

FIG. 26 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 26, the first cable route 832is disposed in the shaft 804 between directions D1 and D4 and the secondcable route 834 is disposed in the shaft 804 between directions D3 andD2.

FIG. 27 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 27, the first cable route 832is disposed in the shaft 804 in the direction of D4 and the second cableroute 834 is disposed in the shaft 804 in the direction of D2.

FIG. 28 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 28, the first cable route 832is disposed in the shaft 804 between directions D4 and D3 and the secondcable route 834 is disposed in the shaft 804 between directions D2 andD1.

FIG. 29 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 29, the first cable route 832is disposed in the shaft 804 in the direction of D3 and the second cableroute 834 is disposed in the shaft 804 in the direction of D1. As isillustrated by the sequence of cross-sectional views in FIGS. 25-29, thefirst cable route 832 and the second cable route 834 each switch to theopposite side of the shaft 804 by rotating through the wall of the shaft804. In this manner the first cable 812 connects a first radial side ofthe tip control lever 802 to the opposite radial side of the tip 808.Similarly, the second cable 814 connected the D3 side of the tip controllever 802 to the D1 side of the tip 808.

FIG. 30 is a cross-sectional view of another embodiment of the shaft 804at the location indicated on FIG. 24. In the embodiment shown, the shaft804 includes the lumen 830, the first cable route 832, and the secondcable route 834. In FIG. 25, the first cable route 832 is disposed inthe shaft 804 in the direction of D1 and the second cable route 834 isdisposed in the shaft 804 in the direction of D3.

FIG. 31 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 31, the first cable route 832is disposed in the lumen 830 towards the direction D1 and the secondcable route 834 is disposed in the lumen 830 towards the direction D3.

FIG. 32 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 32, both the first cableroute 832 and the second cable route 834 are disposed in the center ofthe lumen 830.

FIG. 33 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 33, the first cable route 832is disposed in the lumen 830 towards the direction D3 and the secondcable route 834 is disposed in the lumen 830 towards the direction D1.

FIG. 34 is a cross-sectional view of an embodiment of the shaft 804 atthe location indicated on FIG. 24. In FIG. 34, the first cable route 832is disposed in the shaft 804 in the direction of D3 and the second cableroute 834 is disposed in the shaft 804 in the direction of D1. As isillustrated by the sequence of cross-sectional views in FIGS. 30-34, thefirst cable route 832 and the second cable route 834 each switch to theopposite side of the shaft 804 by crossing through the lumen 830. Inthis manner the first cable 812 connects a first radial side of the tipcontrol lever 802 to the opposite side of the tip 808. Similarly, thesecond cable 814 connects a first radial side of the tip control lever802 to the opposite radial side of the tip 808.

FIG. 35 is a perspective view of an embodiment of a pyramidal-shapedarticulating disc 860. In some embodiments, the pyramidal-shapedarticulating disc 860 includes a first articulating surface 862 and asecond articulating surface 864. Both the first articulating surface 862and the second articulating surface 864 are configured to contact andarticulate against surfaces of adjacent articulating discs towardsdirections D1 or D3. This is shown and described in greater detail withrespect to FIG. 36. Although shown with a rectangular cross-section,some embodiments the pyramidal-shaped articulating disc 860 have a roundor circular cross-section. However, other embodiments of thepyramidal-shaped articulating disc 860 have other cross-sectionalshapes.

In some embodiments, the first articulating surface 862 is formed from afirst surface 866 and a second surface 868 that meet in a ridge 870. Insome embodiments, the first surface 866 and the second surface 868 areflat surfaces. In some embodiments, the ridge 870 is angular and has anangle of between 135 degrees and 179 degrees. Other embodiments withlarger or smaller angles are possible as well. In other embodiments, thefirst surface 866 and the second surface 868 meet at a flat or roundedridge.

Similarly, the second articulating surface 864 is formed from a firstsurface 872 and a second surface 874 that meet in a ridge 876. In someembodiments, the first surface 872 and the second surface 874 are flatsurfaces. In some embodiments, the ridge 876 is angular and has an angleof between 135 degrees and 179 degrees. Other embodiments with larger orsmaller angles are possible as well. In other embodiments, the firstsurface 872 and the second surface 874 meet at a flat or rounded ridge.

FIG. 36 is a side view of an embodiment of a structure 878. Thestructure 878 includes the first cable 812, the second cable 814, afirst pyramidal-shaped articulating disc 880, and a secondpyramidal-shaped articulating disc 882. The first cable 812 and thesecond cable 814 pass through opposite ends of both the firstpyramidal-shaped articulating disc 880 and the second pyramidal-shapedarticulating disc 882. In use, tension may be applied to the first cable812 or the second cable 814 by pulling on the respective cable.

In the example shown in FIG. 36, the first cable 812 is under tension,while the second cable 814 is relaxed. The tension in the first cable812 pulls the edges nearest the first cable 812 of the firstpyramidal-shaped articulating disc 880 and the second pyramidal-shapedarticulating disc 882 together. Because the second cable 814 is relaxed,it allows the edges nearest the first cable 814 of the firstpyramidal-shaped articulating disc 880 and the second pyramidal-shapedarticulating disc 882 to separate. In this manner, the structure 878bends or moves in the direction D1. Conversely, by creating tension inthe second cable 814 and relaxing the first cable 812, the structure 878will bend or move towards direction D3 instead.

Additionally, the structure 878 can also be used to create tension in orrelax the first cable 812 or the second cable 814. By physicallyrotating the first pyramidal-shaped articulating disc 880 towardsdirection D1 while the second pyramidal-shaped articulating disc 882 isheld in place, the first cable 812 is relaxed and the second cable 814is put under tension.

In some embodiments of the articulating stylet 800, one or more of thestructure 878 are included in the tip control lever 802 or the tip 808.

FIG. 37 is a perspective view of an embodiment of a round-shapedarticulating disc 910. In some embodiments, the round-shapedarticulating disc 910 includes a first articulating surface 912 and asecond articulating surface 914. Both the first articulating surface 912and the second articulating surface 914 are configured to contact andarticulate against surfaces of adjacent articulating discs towardsdirections D1 or D3. This is shown and described in greater detail withrespect to FIG. 38. In some embodiments, the first articulating surface912 is round. Similarly, in some embodiments, the second articulatingsurface 914 is also round. Although shown with a rectangularcross-section, some embodiments the round-shaped articulating disc 910have a round or circular cross-section. However, other embodiments ofthe round-shaped articulating disc 860 have other cross-sectionalshapes.

FIG. 38 is a side view of an embodiment of a structure 940. Thestructure 940 includes the first cable 812, the second cable 814, afirst round-shaped articulating disc 942, and a second round-shapedarticulating disc 944. The first cable 812 and the second cable 814 passthrough opposite ends of the first round-shaped articulating disc 942and the second pyramidal-shaped articulating disc 944. In use, tensionmay be applied to the first cable 812 or the second cable 814 by pullingon the respective cable.

In the example shown in FIG. 38, the first cable 812 is under tension,while the second cable 814 is relaxed. The tension in the first cable812 pulls the edges nearest the first cable 812 of the firstround-shaped articulating disc 942 and the second round-shapedarticulating disc 944 together. Because the second cable 814 is relaxed,it allows the edges nearest the second cable 814 of the firstround-shaped articulating disc 942 and the second round-shapedarticulating disc 944 to separate. In this manner, the structure 940bends or moves in the direction D1. Conversely, by creating tension inthe second cable 814 and relaxing the first cable 812, the structure 940will bend or move in direction D3 instead.

Additionally, the structure 940 can also be used to create tension in orrelax the first cable 812 or the second cable 814. By physicallyrotating the first round-shaped articulating disc 942 towards directionD1 while the second round-shaped articulating disc 944 is held in place,the first cable 812 is relaxed and the second cable 814 is put undertension.

In some embodiments of the articulating stylet 800, one or more of thestructure 940 are included in the tip control lever 802 or the tip 808.

FIG. 39 is a side view of an embodiment of the articulating stylet 800.In this example, the tip control lever 802 is bent into position LP3,causing the first cable 812 to relax and the second cable 814 to beunder tension. The first cable 812 and the second cable 814 cross in themiddle of the shaft 804. Accordingly, the tension in the second cable814 causes the tip 808 to bend into position TP1. In this example, thelever position LP3 and the tip position TP1 are both bent insubstantially the same direction.

FIG. 40 is a side view of another embodiment of the articulating stylet800. The embodiment shown in FIG. 40 is similar to the embodiment shownin FIG. 39, except that the first cable 812 and the second cable 814 donot cross in the shaft 804. In this example, the tip control lever 802is bent into position LP4, causing the first cable 812 to be undertension and the second cable 814 to relax. The tension in the firstcable 812 causes the tip 808 to bend into position TP1. In this example,the lever position LP4 and the tip position TP1 are bent in differentdirections.

FIG. 41 is a flowchart of an example endotracheal tube exchange process1000 for removing an existing first endotracheal tube and replacing itwith a new second endotracheal tube using an example tracheal intubationsystem including a laryngoscope. In some embodiments, the articulatingstylet includes a tip control lever, a shaft, and a tip that is directedby the lever.

Initially, at operation 1005, the laryngoscope is positioned to view theglottis of the patient. This step is similar to step 700 of the processillustrated and described in greater detail with respect to FIG. 7. Whenthe laryngoscope is properly positioned, both the glottis and theexisting first endotracheal tube will be visible in the field of view ofthe laryngoscope. The position of the laryngoscope and the field of viewof the laryngoscope are best illustrated in FIG. 42.

Next, at operation 1010, the tip of the articulating stylet ispositioned in the existing first endotracheal tube and advanced until itreaches or goes beyond the tip of the existing first endotracheal tube.This ensures that the tip of the articulating stylet is in the trachea.The shaft of the articulating stylet includes markers that indicate thedistance from the marker to the tip of the articulating stylet. Bymonitoring these markers on the shaft of the articulating stylet, acaregiver can determine when the articulating stylet is fully insertedthrough the endotracheal tube. In some embodiments, the endotrachealtube is transparent or translucent, and the caregiver monitors markers(e.g., the depth-assessment bands) on or near the tip of thearticulating stylet to determine the position of the tip of thearticulating stylet. In other embodiments, the caregivers monitors aseries of numbers on the shaft of the articulating stylet thatcorrespond to the distance from the number to the tip of thearticulating stylet to determine the position of the tip of thearticulating stylet. These numbers on the shaft of the articulatingstylet can be compared to the proximal end of the endotracheal tube.Because the length of the endotracheal tube is known, the position ofthe tip of the articulating stylet can be determined relative to it. Thefinal position of the articulating stylet after operation 1010 is bestillustrated in FIG. 43.

At operation 1015, the existing first endotracheal tube is removed. Insome embodiments, a cuff of the existing first endotracheal tube isdeflated. However, in some embodiments the endotracheal tube does notinclude a cuff. Then, the existing first endotracheal tube is advancedover the articulating stylet towards the lever. In this manner, theexisting first endotracheal tube is removed from the patient. Acaregiver continues to advance the existing first endotracheal tubeuntil it is completely pulled over the lever of the articulating styletand off of the articulating stylet. Throughout this operation, thecaregiver monitors the depth-assessment bands on the tip of articulatingstylet using the laryngoscope to ensure that the articulating styletdoes not move into or out of the patient's trachea. As described withrespect to operation 1010, the position of the tip of the articulatingstylet can be determined by monitoring the depth-assessment bands on thetip of the articulating stylet through a transparent or translucentendotracheal tube or by monitoring depth markers on the shaft of thearticulating stylet. This operation is best shown in FIGS. 44 and 45.

At operation 1020, the new second endotracheal tube is loaded over thelever of the articulating stylet and advanced over the shaft of thearticulating stylet. In some embodiments, a caregiver, usually aphysician or person assisting a physician, grabs the endotracheal tubeand slides it along the articulating stylet until the first end of theendotracheal tube enters the trachea of the patient. Throughout thisoperation, the caregiver also monitors the depth-assessment bands on thetip of articulating stylet using the laryngoscope to ensure that the tipof the articulating stylet does not move into or out of the patient'strachea. As described with respect to operation 1010, the position ofthe tip of the articulating stylet can be determined by monitoring thedepth-assessment bands on the tip of the articulating stylet through atransparent or translucent endotracheal tube or by monitoring depthmarkers or numbers on the shaft of the articulating stylet. Thisoperation is best shown in FIG. 46.

At operation 1025, the cuff of the endotracheal tube is inflated. Thisoperation is similar to operation 730 of the process illustrated anddescribed in greater detail with respect to FIG. 7. However, inembodiments where the endotracheal tube does not include a cuff, thisoperation 1025 is not performed. The endotracheal tube with expandedcuff is illustrated in FIG. 47.

At operation 1030, the articulating stylet and laryngoscope are removed.The shaft of the articulating stylet is pulled out of the endotrachealtube, leaving the endotracheal tube in place. This operation is similarto operation 735 of the process illustrated and described in greaterdetail with respect to FIG. 7.

At operation 1035, the endotracheal tube is connected to a ventilator orbreathing circuit to provide ventilation for the patient. This operationis similar to operation 740 of the process illustrated and described ingreater detail with respect to FIG. 7.

If the articulating stylet is removed from the trachea of the patient atany point during the endotracheal tube exchange process 1000, thecaregiver can notice this with the laryngoscope. The caregiver can thenredirect the articulating stylet back into the trachea using thearticulating tip as described in operations 715 and 720 of the processillustrated in and described in greater detail with respect to FIG. 7.

FIG. 42 is a cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope. In this example, the existing firstendotracheal tube 106 is currently positioned in the trachea of thepatient T and the cuff 172 is inflated. However, in some embodiments,the endotracheal tube 106 does not include the inflatable cuff 172. Theblade 110 of the laryngoscope 102 is disposed in the pharynx of thepatient P. The blade 110 is oriented so that the field of view of theoptical capture device on blade 110 includes the vocal cords V andtrachea T of the patient P, as well as the existing first endotrachealtube 106. The screen 126 displays that the endotracheal tube 106 ispositioned in the trachea T.

FIG. 43 is a cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope. In this example, the articulating stylet 800is inserted into the existing first endotracheal tube 106.

FIG. 44 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope. In this example, the existing firstendotracheal tube 106 is being advanced in the direction D1 along thearticulating stylet 800 out of the trachea T of the patient P andtowards the tip control lever 802 of the articulating stylet 800.

FIG. 45 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope. In this example, the existing firstendotracheal tube 106 has been fully removed and is no longer shown. Thearticulating stylet 800 remains in the proper position in the trachea Tof the patient P. The position of the tip 808 of the articulating stylet800 can be monitored on the screen 126 using the depth-assessment bands142.

FIG. 46 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope. In this example, the new second endotrachealtube 1106 is being advanced in the direction D2 along the articulatingstylet 800 into the trachea T of the patient P.

FIG. 47 is cross-sectional view of a patient P during an endotrachealtube exchange procedure using an example tracheal intubation systemincluding a laryngoscope. In this example, the new second endotrachealtube 1106 has been fully advanced along the articulating stylet 800 andis properly positioned in the trachea T of the patient P. In someembodiments, the cuff 172 is expanded to secure the new secondendotracheal tube 1106 in place. However, in some embodiments, theendotracheal tube 1106 does not include the inflatable cuff 172.

FIG. 48 is a perspective view of an embodiment of a removable handle1200 for the articulating stylet 800. The removable handle 1200 includesa first portion 1202 and a second portion 1204. However, someembodiments of the articulating stylet 800 do not include a handle,removable or otherwise.

The first portion 1202 and the second portion 1204 are physicalstructures and are configured to be gripped. In some embodiments, thefirst portion 1202 and the second portion 1204 are formed from rigid orsemi-rigid materials. In some embodiment, the first portion 1202 and thesecond portion 1204 are formed from plastic or rubber. Yet otherembodiments of the first portion 1202 and the second portion 1204 arepossible as well. In some embodiments, either or both of the firstportion 1202 and the second portion 1204 include finger-shaped groovesto provide an ergonomic and comfortable grip for the caregiver.

In some embodiments, the first portion 1202 and the second portion 1204are joined by a joint 1206. The joint 1206 is an apparatus the couplesthe first portion 1202 to the second portion 1204 and allows movementbetween an open position and a closed position. In some embodiments, thejoint 1206 is a rotational hinge and is configured to allow the firstportion 1202 to rotate relative to the second portion 1204 between anopen position and a closed position. In other embodiments, the joint1206 is a different rotational device. In yet other embodiments, thejoint 1206 is flexible and bends to allow movement between the openposition and the closed position. Yet other embodiments of joint 1206are possible as well. Additionally, some embodiments of the removablehandle include a latching mechanism, such as a latch, hook, or clasp toremovably secure the removable handle 1200 in the closed position.

The first portion 1202 includes a first groove 1208. Similarly, thesecond portion 1204 includes a corresponding second groove 1210. Thefirst groove 1208 and the second groove 1210 are configured to fitagainst the shaft 804 of the articulating stylet 800. In the closedposition, the first groove 1208 and the second groove 1210 areconfigured to wrap around the shaft 804 of the articulating stylet 800.In this manner, the removable handle can be secured to and removed fromthe shaft of the articulating stylet 800. In some embodiments, thesurface of one or both of the first grove 1208 and the second groove1210 are textured to improve the grip on the shaft 804 of thearticulating stylet 800. In other embodiments, one or both of the firstgrove 1208 and the second groove 1210 are lined with a material, such asa high friction material, to improve the grip on the shaft 804 of thearticulating stylet 800.

FIG. 49 is a perspective view of an articulating stylet system 1250. Thearticulating stylet system 1250 includes the articulating stylet 800 andthe removable handle 1200. In some embodiments, the removable handle1200 is removably coupled to the articulating stylet 800. In the exampleshown, the removable handle 1200 is removably coupled to the shaft 804of the articulating stylet 800 below the tip control lever 802. Acaregiver can couple the removable handle 1200 to the shaft 804 when thecaregiver needs to control the tip 808 of the articulating stylet 800.The caregiver can then remove the removable handle 1200 as necessary toremove or insert an endotracheal tube 106 over the tip control lever 802of the articulating stylet 800.

FIG. 50 is a side view of an embodiment of the articulating stylet 800.In this example, the tip control lever 802 is rigid and is rotated intoposition LP1, causing the first cable 812 to relax and the second cable814 to be under tension. Although the tip control lever 802 is rigid, itis joined to the shaft 804 with a plurality of articulating discs 816.The first cable 812 and the second cable 814 cross in the middle of theshaft 804. Accordingly, the tension in the second cable 814 causes thetip 808 to bend into position TP1. In this example, the lever positionLP1 and the tip position TP1 are both bent in substantially the samedirection.

The various embodiments described above are provided by way ofillustration only and should not be construed to limit the claimsattached hereto. Those skilled in the art will readily recognize variousmodifications and changes that may be made without following the exampleembodiments and applications illustrated and described herein, andwithout departing from the true spirit and scope of the followingclaims.

1-9. (canceled)
 10. A tracheal intubation system comprising: a styletcomprising: a shaft having a tip configured to articulate in at leastone direction; at least one depth assessment band on the shaft, the atleast one depth assessment band being visually distinct from an adjacentportion of the shaft; and a control mechanism coupled to the shaft andconfigured to cause the tip of the shaft to articulate in at least onedirection; and a laryngoscope for viewing the at least one depthassessment band and a glottis of a patient at a same time.
 11. Thetracheal intubation system of claim 10, further comprising: a hollowtube configured to be placed in an airway of the patient using thestylet; and a sealing mechanism coupled with the hollow tube andconfigured to seal the airway of the patient.
 12. The trachealintubation system of claim 11, wherein the hollow tube is configured tobe positioned on the stylet as the stylet is inserted into the patient.13. The tracheal intubation system of claim 11, wherein the hollow tubeis configured to fit over the control mechanism.
 14. The trachealintubation system of claim 10, wherein the laryngoscope furthercomprises: a blade having a first end configured to be inserted into amouth of the patient.
 15. The tracheal intubation system of claim 10,wherein the laryngoscope further comprises: an optical capture deviceconfigured to capture an image that includes the at least one depthassessment band and the glottis of the patient.
 16. The trachealintubation system of claim 15, wherein the laryngoscope furthercomprises: a display device configured to display the image captured bythe optical capture device that includes the at least one depthassessment band and the glottis of the patient.
 17. The trachealintubation system of claim 10, wherein the stylet further comprises: anorientation mark on the shaft and configured to indicate a radialorientation of the shaft about a longitudinal axis and a direction ofmovement that the tip is configured to articulate.
 18. The trachealintubation system of claim 10, wherein the at least one depth assessmentband abuts at least one other depth assessment band.
 19. The trachealintubation system of claim 10, wherein the at least one depth assessmentband comprises a visually distinct color or a visually distinct patternfrom a second depth assessment band.
 20. The tracheal intubation systemof claim 10, wherein the control mechanism further comprises: a leverconfigured to cause the tip of the shaft to articulate in at least onedirection in response to a movement of the lever.
 21. The trachealintubation system of claim 10, wherein: the tip of the shaft articulatesin a first direction when the control mechanism pivots in a seconddirection; and the tip of the shaft articulates in a third directiondifferent than the first direction when the control mechanism pivots ina fourth direction different than the second direction.
 22. A styletadapted for mounting an endotracheal tube, the stylet comprising: ashaft having a tip configured to articulate in at least one direction;at least one depth assessment band on the shaft, the at least one depthassessment band being visually distinct from an adjacent portion of theshaft, wherein the at least one depth assessment band is configured toindicate a placement of the stylet when viewed in proximity to a glottisof a patient; and a control mechanism coupled to the shaft andconfigured to cause the tip of the shaft to articulate in at least onedirection.
 23. The stylet of claim 22, wherein the at least one depthassessment band contacts at least one other depth assessment band. 24.The stylet of claim 22, wherein the at least one depth assessment bandfurther comprises: a first depth assessment band having a firstdimension along a length of the shaft; and a second depth assessmentband having a second dimension along the length of the shaft, the firstdimension different than the second dimension.
 25. The stylet of claim22, wherein the at least one depth assessment band further comprises: afirst depth assessment band having a first color; and a second depthassessment band having a second color different than the first color.26. The stylet of claim 22, wherein the at least one depth assessmentband further comprises: a first depth assessment band having a firstpattern; and a second depth assessment band having a second patterndifferent than the first pattern.
 27. The stylet of claim 22, whereinthe at least one depth assessment band further comprises: a first depthassessment band having a first color and a first pattern; and a seconddepth assessment band having a second color different than the firstcolor and a second pattern different than the first pattern.
 28. Thestylet of claim 22, further comprising: an orientation mark on the shaftand configured to indicate a radial orientation of the shaft about alongitudinal axis a direction of movement that the tip is configured tomove.
 29. The stylet of claim 22, wherein the control mechanism furthercomprises: a lever configured to cause the tip of the shaft toarticulate in at least one direction in response to a movement of thelever.
 30. The stylet of claim 22, wherein: the tip of the shaftarticulates in a first direction when the control mechanism pivots in asecond direction; and the tip of the shaft articulates in a thirddirection different than the first direction when the control mechanismpivots in a fourth direction different than the second direction. 31.The stylet of claim 22, wherein the tip further comprises: a distal endthat is rounded and closed.
 32. The stylet of claim 22, wherein theshaft further comprises: an exterior surface configured to be sterilizedwithout using an autoclave.
 33. A method of positioning an endotrachealtube in a patient, comprising: inserting a laryngoscope in a mouth ofthe patient; mounting the endotracheal tube on a stylet having a tipconfigured to articulate in more than one direction and at least onedepth assessment band on an exterior surface of the stylet, the at leastone depth assessment band being visually distinct from an adjacentportion of the stylet; inserting the stylet into an airway of thepatient; monitoring, using the laryngoscope, a position of the at leastone depth assessment band relative to a glottis of the patient;modifying a depth that the stylet is inserted into the airway of thepatient until the at least one depth assessment band indicates that thestylet is positioned at an appropriate depth in the patient based atleast in part on; and sliding the endotracheal tube along the stylet andinto a trachea of the patient.
 34. The method of claim 33, furthercomprising: determining that the endotracheal tube is positioned in azone of caution based at least in part on monitoring the position of theat least one depth assessment band relative to the glottis of thepatient, wherein modifying the depth of the stylet is based at least inpart on determining that the endotracheal tube is positioned in the zoneof caution.
 35. The method of claim 33, further comprising: viewing thetrachea of the patient on a display associated with the laryngoscope,wherein monitoring the position of the at least one depth assessmentband uses one or more images captured by an optical capture device ofthe laryngoscope.
 36. The method of claim 33, wherein inserting thelaryngoscope further comprises: inserting a blade of the laryngoscope inthe mouth of the patient, wherein inserting the stylet into the airwayof the patient is based at least in part on inserting the blade.
 37. Themethod of claim 33, further comprising: articulating the tip of thestylet towards an entrance of the trachea, wherein monitoring theposition of the at least one depth assessment band relative to theglottis of the patient is based at least in part on articulating the tipof the stylet.
 38. The method of claim 33, wherein modifying the depththat the stylet is inserted into the airway of the patient furthercomprises: inserting the stylet at least partially into the airway ofthe patient based at least in part on monitoring the position of the atleast one depth assessment band relative to the glottis of the patient.39. The method of claim 33, wherein modifying the depth that the styletis inserted into the airway of the patient further comprises:withdrawing the stylet at least partially out of the airway of thepatient based at least in part on monitoring the position of the atleast one depth assessment band relative to the glottis of the patient.